Cellular Immunotherapy in Treating Patients With High-Risk Acute Lymphoblastic Leukemia
Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients With High-Risk CD19+ Acute Lymphoblastic Leukemia
Doctors at the City of Hope Medical Center are recruiting participants with acute lymphoblastic leukemia (ALL) that has recurred or persisted, for an investigatory gene-modified immunotherapy. Through gene editing outside the body, the patient’s own (autologous) immune T-cells will be programmed to attack their leukemia.
Researchers use a virus to insert a gene into the patient’s T-cells, which equips the cells to target their cancer. The treatment will require apheresis (drawing the blood to extract the T-calls) then, after they are gene-modified in the lab over several weeks, a course of chemotherapy will be required prior to an infusion of the cells. One infusion will be required and 2 may be provided, within a 28-day period, Follow up will occur at 12 months and for a total of 15 years.
- Be 18 years of age or older
- Meet cancer screening to ensure their leukemia meets study criteria
- Not be pregnant or breastfeeding, be willing to take birth control
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Blood will be drawn from the patient and genetically engineered in the lab.
- A course of chemotherapy is administered to reduce the patient’s existing bone marrow, giving room for the new cells to grow.
- A single infusion of the engineered cells will be given, and the patient’s reaction observed. After 28 days, an optional second dose may be given.
- After treatment, blood lab tests and follow up will be required at regular intervals to check the patient’s disease response.
LOCATIONS AND CONTACTS:
The study site is at the City of Hope Medical Center in Duarte, California. Map.
Samer K. Khaled | 626-256-4673 | [email protected]
The National Cancer Institute (NCI)
City of Hope Medical Center
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